FDA Considering Rule Change Affecting Suits Against Generic Drug Makers

Through the years, many of our posts here at Abnormal Use have focused on the Food and Drug Administration and, in particular, its treatment of generic and brand name drugs.  Despite the drugs’ apparent ability to be substituted for one another medically, the FDA treats generics and brand names very differently in terms of the manufacturers’ liability, and the ability to change or alter warning labels.

In broad terms, generic drug manufacturers have very little control over the labels that are placed on their products.  The labeling and warning requirements promulgated by the FDA with regard to a particular brand name drug are simply passed along to the generic form of the drug—in other words, generic drug manufacturers are required to provide the exact same warnings as the brand name drug.  The lack of control, however, is met with a corresponding insulation from liability—in the past, the Supreme Court has shielded generic drug manufacturers from lawsuits involving allegations of inadequate labeling.

All of that may be changing, thanks to the U.S. Supreme Court’s June 2013 ruling in the case of Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466, 186 L. Ed. 2d 607 (2013) [PDF].

Some background is necessary here.  Plaintiff Karen Bartlett suffered severe injuries allegedly caused by a generic anti-inflammatory drug, sulindac, manufactured by Mutual Pharmaceutical Co.  Bartlett, who took the drug for shoulder pain, suffered severe burns over much of her body and is now nearly blind.  The Court’s opinion is difficult to read in some places, outlining Bartlett’s medical ordeal in graphic detail.  Bartlett spent months in a medically induced coma, was tube-fed for a year and underwent a dozen eye surgeries. Rather than focusing on labeling requirements—a sure loser of an argument based on precedent—Bartlett alleged that the drug was designed defectively and was unreasonably dangerous.  On appeal, the Boston-based appeals court ruled in favor of the damages awarded to Ms. Bartlett, opining that the Mutual Pharmaceutical could have (and by implication, probably should have) decided not to sell sulindac at all. For its part, the Supreme Court did not see the case the same way, and reversed the award, saying the company was “not required to cease acting altogether in order to avoid liability.”  The high court ruled in favor of the manufacturer, causing a virtual uproar in the consumer drug world.  As cited in this Wall Street Journal online article, “Critics have argued that it makes little sense that a consumer’s right to sue depends upon whether he took a brand-name drug or a generic equivalent.”

Fast forward five months, and the FDA has taken note of the uproar.  It recently proposed to grant (or burden) the generic drug manufacturers with the same ability to change their labels as brand name manufacturers, with the FDA ostensibly requiring the same rigorous review process as applies to brand name drugs.  Quoting The Wall Street Journal law blog’s analysis:

If adopted, the new regulation would remove a legal distinction that prompted the Supreme Court to shield generic drug makers from product-liability lawsuits, even while allowing such claims against manufacturers of brand-name drugs.

The implication being, of course, that it would open up generic drug makers to liability.  As is expected with any major change to regulatory policy, reaction has been mixed:

Public Citizen, which had petitioned for the FDA rule change, praised the move Friday, saying it would “provide added protection to the tens of millions of people who regularly use generic drugs.”  The Generic Pharmaceutical Association reacted cautiously, saying it is concerned that multiple labels on the same drug “could drive up costs…and should be approached very carefully.”

This is a development to be watched carefully.  Depending on how the FDA amends its rules, a flood of litigation could be building right behind the change.  It might also mean the demise of some generic drug manufacturers who don’t wish to be in the lawsuit business.  It’s going to be an interesting season at the FDA, for sure.

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